Regulating Hope: India's ART Act, Global Best Practices, and the Drive for Research Excellence
Assisted Reproductive Technology (
ART
) has transformed fertility care, bringing renewed hope to countless individuals and couples facing infertility. In response to the growing demand and complexity of ART services, India introduced the Assisted Reproductive Technology (Regulation) Act, 2021—an important step toward creating a safe, ethical, and accountable environment for reproductive treatments.
By setting clear standards and oversight mechanisms, the Act lays a strong foundation for responsible practice. As the field continues to evolve, there is an opportunity to build on this progress by enabling a supportive ecosystem for research, innovation, and collaboration—ensuring that India remains responsive to emerging technologies while upholding the rights and well-being of all stakeholders.
The ART Act: India's Regulatory Milestone
The Assisted Reproductive Technology (Regulation) Act, 2021 was introduced to regulate and supervise ART clinics and banks across India, aiming to prevent misuse and ensure that all procedures are carried out in a safe and ethical manner.
To achieve this, the Act established a comprehensive, multi-tiered regulatory framework comprising the National and State ART and
Surrogacy Boards
, a National Registry, and designated authorities at both the central and state levels.
These bodies are responsible for overseeing the registration, functioning, and monitoring of ART clinics and banks, enforcing prescribed standards, and maintaining a central database to support transparency and informed policy-making.
Among the Act's key provisions are the mandatory registration of all ART clinics and banks, the requirement for written informed consent from all parties involved, and strict protocols for record-keeping and reporting.
Additionally, the Act regulates the sourcing, storage, and handling of gametes, explicitly prohibits sex selection and the commercial sale of gametes or embryos, and includes safeguards to protect the rights and welfare of children born through ART procedures.
Together, these measures address a wide range of ethical, medical, and legal concerns, while fostering responsible advancements in the field of reproductive medicine.
Global Perspectives
United States
The US model relies on a combination of federal oversight (primarily through the Centers for Disease Control and Prevention and the Food and Drug Administration) and state-level regulation.
Accreditation by professional bodies such as the American Society for Reproductive Medicine (ASRM) and the Society for Assisted Reproductive Technology (SART) ensures high standards of practice and transparent outcome reporting. However, there is significant variability in access and donor anonymity laws across states.
Spain
Spain is recognized for its progressive, patient-centric approach. The country's national law guarantees broad access to ART, including for single women and same-sex couples. Donor anonymity is strictly enforced, and a comprehensive national registry tracks all procedures and outcomes. Spain's robust oversight has made it a global destination for fertility care.
China
China's ART sector is tightly regulated by the government, with access limited to married couples. Clinics and banks operate under strict licensing, and there are clear restrictions on embryo storage and use. The centralized approach ensures uniform standards but limits individual choice.
Japan
Japan's regulatory environment is evolving, with guidelines issued by professional societies and increasing government involvement.
Donor anonymity is maintained, and there is a cautious approach to expanding ART services, reflecting societal consensus and ethical considerations.
India's take on Research and Innovation
India's approach to research and innovation in assisted reproductive technology (ART), including emerging fields like genetic testing and embryo research is evolving. India's in vitro fertilization (IVF) industry is undergoing a significant transformation, driven by rising infertility rates, technological advancements, and increased awareness of fertility treatments.
Guidelines and Regulation of ART-Related Research and ICMR
India has established regulatory frameworks for ART through the Assisted Reproductive Technology (ART) Act, 2021, and the
Surrogacy
(Regulation) Act, 2021, which set out ethical and safety standards for ART practices.
The ART Act includes strict guidelines on embryo use, prohibiting embryos from being used for purposes other than ART or research, and bans the transfer of gametes/embryos outside India for research or as a source of stem cells. Embryo donation for research is allowed only in specific cases and with written consent.
Genetic testing and pre-implantation genetic testing (PGT) are mandated in certain cases to screen embryos for genetic diseases or when medically indicated, reflecting a cautious but proactive approach to integrating new technologies.
However, research involving human germline gene therapy, reproductive cloning, and clinical trials with xenogeneic cells is not permitted. In vitro genome modification of embryos (not carried to term) is allowed, but only up to 14 days of fertilization.
As of 2025, India does not have specific laws regulating human embryo gene editing. Instead, oversight is provided through guidelines issued by the Indian Council of Medical Research (ICMR).
According to the National Guidelines for Stem Cell Research, genome editing—including methods like CRISPR-Cas9—on stem cells, germ-line cells, gametes, or embryos is allowed only for in vitro studies. Such research must be reviewed by the IC-SCR, IEC, and IBSC, and approved by the RCGM. Clinical application of germline gene editing is currently strictly prohibited.
Need to Incentivize Research and Innovation
There is broad recognition among policymakers and experts of the need to incentivize research and innovation in the medical field, especially in fertility and ART. The government has launched the National Policy on Research and Development and Innovation in Pharma-MedTech Sector and the PRIP (Promotion of Research and Innovation in
Pharma MedTech Sector
) scheme, which aims to:
Create a regulatory environment that facilitates innovation and research in product development.Incentivize private and public investment in innovation through fiscal and non-fiscal measures.Promote industry-academia collaboration and support research in priority areas, including stem cell therapy and complex generics. Nitiz Murdia – Managing Director Indira IVF says, 'Experts and stakeholders in the fertility sector highlight the need for greater awareness, expanded access, insurance coverage, and government-backed initiatives to address India's fertility challenges and to support the growth of ART services and research'.
References:
https://www.sart.org/
https://prsindia.org/billtrack/the-assisted-reproductive-technology-regulation-bill-2020
https://www.indiacode.nic.in/bitstream/123456789/17031/1/A2021-42%20.pdf
https://pmc.ncbi.nlm.nih.gov/articles/PMC10112746/
https://www.asrm.org/advocacy-and-policy/fact-sheets-and-one-pagers/art-oversight-lessons-for-the-us-from-abroad/
https://www.cambridge.org/core/services/aop-cambridge-core/content/view/ADA0ECC225D2FFF0D41C2A6061B01585/S0963180122000603a.pdf/reluctant-rulers-policy-politics-and-assisted-reproduction-technology-in-japan.pdf
https://www.reuters.com/world/china/beijing-cover-ivf-other-fertility-treatments-couples-july-2023-06-15/
https://pmc.ncbi.nlm.nih.gov/articles/PMC4729105/
https://nmji.in/legal-subtleties-of-the-indian-assisted-reproductive-technology-act-of-2021/
https://pubmed.ncbi.nlm.nih.gov/30675969/
https://pmc.ncbi.nlm.nih.gov/articles/PMC6332765/
https://technical-regulation-information-system.ec.europa.eu/en/notification/23748/text/D/EN
https://pmc.ncbi.nlm.nih.gov/articles/PMC8259134/
This article is written by Nitiz Murdia, Managing Director at Indira IVF
(DISCLAIMER: The views expressed are solely of the author and ETHealthworld.com does not necessarily subscribe to it. ETHealthworld.com shall not be responsible for any damage caused to any person/organisation directly or indirectly)
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